Home About Qualtech NEWS THAILAND: Ministry of Public Health Announce the Draft of the Products Containing Alcohol for Humans and Animals Sterilization - February 2019
THAILAND: Ministry of Public Health Announce the Draft of the Products Containing Alcohol for Humans and Animals Sterilization - February 2019

February 18, 2019

On December 28, 2018 ThaiFDA has published the draft of the announcement regarding products containing alcohol for humans and animals sterilization. Based on the powers under Section 4 (3), Section 5, Section 6 (2) (4) and (13), Section 44, paragraph two and Section 45, paragraph two of the Medical Device Act BE 2551, the Minister of Public Health by The recommendations of the Medical Device Committee announced as follows:

1.      In this announcement " Products containing alcohol for humans and animal sterilization" means product which contains ethyl alcohol/ethanol or isopropyl alcohol/isopropanol, combined from or more that 70% volume and water only in a form of cotton ball, swab, swab stick, pad, applicator, unit dose/single dose/individual packaging that have direct contact on skin to for wound sterilization. 

  

2.      All products containing alcohol for humans and animal sterilization, manufacturer and importer must prepared the registration of medical device to be notified in order to import the product.

  

3.      All products containing alcohol for humans and animal sterilization must have standard in accordance with the requirement of Drugs by the Minister, along with Microbiological Attributes test result and Stability test results that follows ASEAN guideline on Stability Study of Drug Product.

  

4.      Must be produced by manufacturers that have been certified for production quality for such products in accordance with national standards or international standards such as standards, criteria and good methods in the production of medicines Pharmaceutical Inspection Co-operation Scheme (PIC/S) Criteria and methods for good production of medical devices (GMP) International organization standards for standards 13485 (ISO 13485: 2003 or ISO 13485: 2016) or newer.

  

5.      Manufacturer and importer of products containing alcohol for humans and animal sterilization must provide labelling in Thai or English that are clearly readable on product packages or its container. With at least these following items:

(a)    Trade name of the product;

(b)   Name and concentration of all components;

(c)    Name and address of the manufacture site. For importer, provide address of the manufacturer;

(d)   Year and Month or Month and Year for manufacture date. Manufacture year must be 4 digits;

(e)    Year and Month or Month and Year for expiry date or use before. Expiry date must be 4 digits;

(f)     Number or letter indicating LOT number or manufacture number;

(g)    Number of the registration license of medical device to be notified; 

(h)   Instruction for use and storage methods and precautions;

(i)      Message of "For disinfecting the skin or wiping around the wound";

(j)      Message of "Single use only";

(k)    Message of "Sterile and sterile methods (if applicable)";

(l)      Message of "For external use only";

(m)Message of "Flammable substance. Keep away from fire or flame";

(n)   Message of “Do not use with patients with immune deficiency. Or patients at the vascular catheter "shown in red letters;

(o)   Message of "Do not use if the package is damaged or torn" shown in red letters, and

(p)   Message "Please read the medical device documentation

Labelling of clause 5 (d)(e)(g)(h)(j)(k)(l)(m)(n)(o)(p) must be in Thai.

  

6.      In order to sell products containing alcohol for humans and animals sterilization in Thailand, products must labelling in Thai or other languages that are clearly readable on product packages or its container. With at least these following items:

(a)    Trade name of the product;                                     

(b)   Name and concentration of all components;   

(c)    Name and address of the manufacture site. For importer, provide address of the manufacturer;  

(d)   Instruction for use and storage methods and precautions;

(e)    Message of "For disinfecting the skin or wiping around the wound”;

(f)     Message of "Single use only"; 

(g)    Message of "Sterile and sterile methods (if applicable)";          

(h)   Message of "For external use only", and    

(i)      Message of "Flammable substance. Keep away from fire or flame”.

  

7.      In the case of importing products containing alcohol for humans and animals sterilization, the importers must prepared the labelling on the packages according to clause 5,6 before selling, within thirty days from the date that  medical device has checked for release.

  

8.      All products containing alcohol for humans and animals sterilization that manufactured for export only must meet the standard and requirements for labelling according to the agreement between the 2 parties.

  

9.      Registration of the drug certificate holder,  for products containing alcohol for humans and animals sterilization before the effective date of this notification and wishes to continue operating, must apply for establishment import license along with preparing the registration of medical device to be notified within the period of 30 days from the effective date of this notification.

  

10.  This announcement shall come into force after 180 days from the date following the date of its publication in Government Gazette onwards.

 

Reference

Official press

 
Home About Qualtech NEWS THAILAND: Ministry of Public Health Announce the Draft of the Products Containing Alcohol for Humans and Animals Sterilization - February 2019